Resilient Together for Dementia

NCT ID: NCT06421545

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-19

Study Completion Date

2025-03-06

Brief Summary

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The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).

Detailed Description

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Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.

Conditions

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Alzheimer's Disease and Related Dementias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Open Pilot RT-D Dyads

Persons living with dementia (PWDs) and their spousal care-partners

Group Type EXPERIMENTAL

Resilient Together for Dementia

Intervention Type BEHAVIORAL

A novel live video dyadic resiliency intervention

Interventions

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Resilient Together for Dementia

A novel live video dyadic resiliency intervention

Intervention Type BEHAVIORAL

Other Intervention Names

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RT-D

Eligibility Criteria

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Inclusion Criteria

* Recent (\~1 month) chart documented ADRD diagnosis,
* ADRD symptom onset after age 65 ,
* cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
* cognitive awareness of his/her problems (as determined by the treating neurologist), and
* ability to understand study and research protocol, as determined by a standardized teach-back method assessment84.


* English speaking adults (18 years or older),
* dyad lives together,
* at least one partner endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression scale subscales)

Exclusion Criteria

* patient is deemed inappropriate by the neurology team,
* either partner has a co-occurring terminal illness,
* patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Sarah Bannon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Bannon

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Brain Injury Research Center at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

References

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McCage S, Walker K, Cornelius T, Parker RA, Dams-O'Connor K, Dickerson B, Ritchie C, Vranceanu AM, Bannon S. A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-Partners Early After Diagnosis: Protocol for Open Pilot of Resilient Together for Dementia. JMIR Res Protoc. 2025 Jan 15;14:e60382. doi: 10.2196/60382.

Reference Type DERIVED
PMID: 39814366 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1K23AG075188-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 23-0519

Identifier Type: -

Identifier Source: org_study_id

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